Senior Manager, Statistical Programming

Position Overview

The Senior Manager, Statistical Programming will provide planning, execution, and quality of SAS programming deliverables supporting the analysis and reporting of clinical trial results. This role also ensures the submission-readiness of study data packages in accordance with CDISC standards, applicable regulatory guidance, and internal standards. This role will also collaborate cross-functionally with Biostatistics, Data Management, Clinical Development, and others to contribute to the development and continuous improvement of statistical programming standards, processes, tools and infrastructure within the Biometrics department.

Responsibilities

• Lead statistical programming activities for 1 or 2 assigned clinical studies, ensuring high-quality deliverables across the full study lifecycle.
• Develop and/or view programming specifications based on the Statistical Analysis Plan and oversee the creation, validation, and delivery of CDISC-compliant SDTM and ADaM datasets, TLFs, Define.xml, and reviewer guides.
• Provide hands-on SAS programming support for key analyses, data exploration, ad hoc requests, and internal or regulatory deliverables, as needed.
• Manage study programming timelines, coordinate dependencies, proactively identify risks, and ensure alignment with cross-functional study plans and key milestones.
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Safety teams to review requirements, refine specifications, and resolve data or programming issues.
• Review Data Management Plans, case report forms, data transfer specifications, external/vendor data specifications, and validation-related documentation to ensure data quality and downstream programming readiness.
• Oversee CRO statistical programming activities, review outputs for accuracy and compliance, and ensure timely, high-quality delivery of datasets and analysis results.
• Validate CRO-generated SDTM/ADaM datasets, TLFs, and submission components using industry-standard tools such as Pinnacle 21 to access CDISC compliance and support resolution of identified issues.
• Develop and maintain SAS macros, utilities, and programming standards, and reusable tools to improve efficiency, consistency, and scalability across studies.
• Ensure adherence to CDISC standards, regulatory expectations, departmental SOPs, and best practices for statistical programming and data traceability.
• Mentor and provide technical oversight to junior programmers or contractors supporting assigned studies.
• Contribute to and, where appropriate, lead departmental initiatives, process improvements, and cross-functional projects beyond assigned study responsibilities.

Qualifications

• A master’s degree (or higher) in Statistics, Computer Science or other closely related field to programming with minimum 6+ years of relevant pharmaceutical/biotech industry experience.
• Requires solid knowledge of statistical programming principles, clinical trials process and regulatory requirements.
• Prior NDA submission and regulatory agency interaction experience highly desirable.
• Prior Oncology/Hematology experience highly desirable.

Knowledge and Skills

• Dynamic self-starter; agile learner; strategic and creative thinker.
• Demonstrated strong problem solving and risk-mitigation skills.
• Excellent verbal/written and interpersonal skills required to communicate and collaborate effectively with cross-functional teams (clinical operations, Scientists, Medical Monitors and Statisticians) in face-to-face conversation, by telephone, and by email.
• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
• Strong, well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint, API based data extracts, ETL principles) and knowledge of industry standards (CDISC, SDTM, CDASH, ADaM).